Starpharma (ASX:SPL) achieved a regulatory milestone following a Type C guidance meeting with the United States Food and Drug Administration.
The agency provided positive feedback on the proposed clinical development strategy and study design for DEP HER2, a novel radiotherapy candidate, clearing the path for its inaugural first-in-human phase 1 clinical trial.
DEP HER2 is a sophisticated dendrimer conjugate designed to target HER2 receptors, delivering a potent lutetium-177 radionuclide payload directly to cancer cells.
The precision approach is initially being developed to treat patients with locally advanced or metastatic HER2-overexpressing gastric and gastroesophageal junction cancers—particularly those who have already exhausted standard HER2-targeted therapies.
The FDA acknowledged that the patients represent a population with significant unmet medical need, a recognition that may facilitate future accelerated development pathways, such as Fast Track designation.
The upcoming phase 1 study is scheduled to commence in Europe during the second half of 2026.
The trial will enrol up to 15 patients to rigorously evaluate the safety, tolerability, and pharmacokinetics of the treatment, while also characterising its biodistribution and organ radiation dosimetry.
At the time of reporting, Starpharma's share price was $0.70.